[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR291.505]

[Page 157-179]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 291--DRUGS USED FOR TREATMENT OF NARCOTIC ADDICTS--Table of Contents
 
Sec. 291.505  Conditions for the use of narcotic drugs; appropriate methods

 of professional practice for medical treatment of the narcotic addiction of

 various classes of narcotic addicts under section 4 of the Comprehensive Drug Abuse Prevention and Control Act of 1970.

    (a) Definitions. As used in this part:
    (1) Detoxification treatment means the dispensing of a narcotic drug 
in decreasing doses to an individual to alleviate adverse physiological 
or psychological effects incident to withdrawal from the continuous or 
sustained use of a narcotic drug and as a method of bringing the 
individual to a

[[Page 158]]

narcotic drug-free state within such period. There are two types of 
detoxification treatment: short-term detoxification treatment and long-
term detoxification treatment.
    (i) Short-term detoxification treatment is for a period not in 
excess of 30 days.
    (ii) Long-term detoxification treatment is for a period more than 30 
days but not in excess of 180 days.
    (2) Maintenance treatment means the dispensing of a narcotic drug, 
at relatively stable dosage levels, in the treatment of an individual 
for dependence on heroin or other morphine-like drug. There are two 
types of maintenance treatment: comprehensive maintenance treatment and 
interim maintenance treatment.
    (i) Comprehensive maintenance treatment is maintenance treatment 
provided in conjunction with a comprehensive range of appropriate 
medical and rehabilitative services.
    (ii) Interim maintenance treatment is maintenance treatment provided 
in conjunction with appropriate medical services while a patient is 
awaiting transfer to comprehensive maintenance treatment.
    (3) A medical director is a physician, licensed to practice medicine 
in the jurisdiction in which the program is located, who assumes 
responsibility for the administration of all medical services performed 
by the narcotic treatment program including ensuring that the program is 
in compliance with all Federal, State, and local laws and regulations 
regarding the medical treatment of narcotic addiction with a narcotic 
drug.
    (4) A medication unit is a facility established as part of, but 
geographically dispersed, i.e., separate from a narcotic treatment 
program from which licensed private practitioners and community 
pharmacists--
    (i) Are permitted to administer and dispense a narcotic drug, and
    (ii) Are authorized to collect samples for drug testing or analysis 
for narcotic drugs.
    (5) Narcotic dependent means an individual who physiologically needs 
heroin or a morphine-like drug to prevent the onset of signs of 
withdrawal.
    (6) A narcotic treatment program is an organization (or a person, 
including a private physician) that administers or dispenses a narcotic 
drug to a narcotic addict for maintenance or detoxification treatment, 
provides, when appropriate or necessary, a comprehensive range of 
medical and rehabilitative services, is approved by the State authority 
and the Food and Drug Administration, and that is registered with the 
Drug Enforcement Administration to use a narcotic drug for the treatment 
of narcotic addiction.
    (7) A program sponsor is a person (or representative of an 
organization) who is responsible for the operation of a narcotic 
treatment program and who assumes responsibility for all its employees 
including any practitioners, agents, or other persons providing services 
at the program (including its medication units).
    (8) The term services, as used in this part, includes medical 
evaluations, counseling, rehabilitative and other social programs (e.g., 
vocational and educational guidance, employment placement), which will 
help the patient become a productive member of society.
    (9) A State authority is the agency designated by the Governor or 
other appropriate official to exercise the responsibility and authority 
within the State or Territory for governing the treatment of narcotic 
addiction with a narcotic drug.
    (10) The term HIV disease means infection with the etiologic agent 
for acquired immunodeficiency syndrome.
    (b) Organizational structure and approval requirements--(1) 
Organizational structure. (i) A narcotic treatment program may be an 
independent organization or part of a centralized organization. For 
example, if a centralized organizational structure consists of a primary 
facility and other outpatient facilities, all of which conduct initial 
evaluation of patients and administer or dispense medication, the 
primary facility and each outpatient facility are separate programs, 
even though some services (e.g., the same hospital or rehabilitative 
services) are shared.
    (ii) The program sponsor shall submit to the Food and Drug 
Administration and the State authority a description of the 
organizational structure of the program, the name of the persons 
responsible for the program, the address

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of the program, and the responsibilities of each facility or medication 
unit. The sources of funding for each program shall be listed and the 
name and address of each governmental agency providing funding shall be 
stated.
    (iii) Where two or more programs share a central administration 
(e.g., a city or State-wide organization), the person responsible for 
the organization (administrator or program sponsor) is required to be 
listed as the program sponsor for each separate participating program. 
An individual program shall indicate its participation in the central 
organization at the time of its application. The administrator or 
sponsor may fulfill all recordkeeping and reporting requirements for 
these programs, but each program must continue to receive separate 
approval.
    (iv) One physician may assume primary medical responsibility for 
more than one program and be listed as medical director. If a physician 
assumes medical responsibility for more than one program, a statement 
documenting the feasibility of the arrangement is required to be 
attached to the application.
    (v) Interim maintenance treatment. A public or nonprofit private 
narcotic treatment program may provide interim maintenance treatment 
only if the program also provides comprehensive maintenance treatment to 
which interim maintenance treatment patients may be transferred.
    (2)(i) Program approval. Before a narcotic treatment program may be 
lawfully operated, the program, whether an outpatient facility or a 
private practitioner, shall submit the applications specified in this 
section simultaneously to the Food and Drug Administration and the State 
authority and must receive the approval of both, except as provided for 
in paragraph (h)(5) of this section. Before granting approval, the Food 
and Drug Administration will consult with the Drug Enforcement 
Administration, Department of Justice, to ascertain if the program is in 
compliance with Federal controlled substances laws. Each physical 
location within any program is required to be identified and listed in 
the approval application. At the time of application for approval, the 
program sponsor shall indicate whether medication will be administered 
or dispensed at the facility. Before medication may be administered or 
dispensed at a location not previously approved for this purpose, the 
program is required to obtain approval from FDA and the State agency. 
However, no approval is necessary, but notification is required when a 
facility in which medication is administered or dispensed is deleted by 
a program. In that event, the program shall notify the Food and Drug 
Administration and the State authority within three weeks of the 
deletion. Similarly, addition or deletion of facilities which provide 
services other than administering or dispensing medication is also 
permitted without approval, but notification must be made within 3 weeks 
to the Food and Drug Administration and the State authority about the 
addition and/or deletion.
    (ii) Exemption of Federal programs. The provisions of this section 
requiring approval (or permitting disapproval or revocation of approval) 
by the State authority, compliance with requirements imposed by State 
law, or the submission of applications or reports required by the State 
authority do not apply to programs operated directly by the Veterans' 
Administration or any other department or agency of the United States. 
Federal agencies operating narcotic treatment programs have agreed to 
cooperate voluntarily with State agencies by granting permission on an 
informal basis for designated State representatives to visit Federal 
narcotic treatment programs and by furnishing a copy of Federal reports 
to the State authority, including the reports required under this 
section.
    (iii) Services. Each narcotic treatment program shall provide 
medical and rehabilitative services and programs. (See paragraph (d)(4) 
of this section.) These services should normally be made available at 
the primary facility, but the program sponsor may enter into a formal 
documented agreement with private or public agencies, organizations, or 
institutions for these services if they are available elsewhere. The 
program sponsor, in any event, must be able to document that medical and 
rehabilitative services are fully available to patients.

[[Page 160]]

    (iv) Prohibition against unapproved use of narcotic drugs. No 
prescribing, administering, or dispensing of a narcotic drug for the 
treatment of narcotic addiction may occur without prior approval by the 
Food and Drug Administration and the State authority, except as provided 
for in paragraph (h)(5) of this section, unless specifically exempted by 
this section.
    (v) Approved narcotic drugs for use in treatment programs. The 
following narcotic drugs have been approved for use in the treatment of 
narcotic addiction: Methadone and Levo-Alpha-Acetyl-Methadol (LAAM).
    (vi) Interim maintenance treatment program approval. Before a public 
or nonprofit private narcotic treatment program may provide interim 
maintenance treatment, the program must receive approval of both the 
Food and Drug Administration and the chief public health officer of the 
State. Before such approval is granted, the program must provide the 
Food and Drug Administration with certification from the chief public 
health officer of the State that:
    (A) Such officer does not object to the authorization of programs 
providing interim maintenance treatment in the State and that programs 
seeking such authorization are unable to place patients in a public or 
nonprofit private comprehensive treatment program within a reasonable 
geographic area within 14 days of the time patients seek admission to 
such programs;
    (B) The authorization of programs providing interim maintenance 
treatment in the State will not reduce the capacity of comprehensive 
programs in the State to admit individuals to these programs (relative 
to the date on which such officer so certifies);
    (C) The State guarantees that individuals enrolled in interim 
maintenance treatment will be transferred to comprehensive programs not 
later than 120 days, as provided by section 1923 of the Public Health 
Service Act (the PHS Act) and applicable regulations; and
    (D) Requests for authorization should be submitted to the address 
specified in paragraph (l) of this section.
    (3)(i) Medication unit. A program may establish a medication unit to 
facilitate the needs of patients who are stabilized on an optimal dosage 
level. To lawfully operate a medication unit, the program shall, for 
each separate unit, obtain approval from the Food and Drug 
Administration, the Drug Enforcement Administration, and the State 
authority, except as provided for in paragraph (h)(5) of this section. 
The Food and Drug Administration, in determining whether to approve a 
medication unit, will consider the distribution of units within a 
particular geographic area. Any new medication unit is required to 
receive approval before it may lawfully commence operation.
    (ii) Revocation of approval. If the Food and Drug Administration 
revokes the primary program's approval, the approval for any medication 
unit associated with the program is deemed to be automatically revoked. 
The Food and Drug Administration's revocation of the approval of a 
particular medication unit, will not, in and of itself, affect the 
approval of the primary program.
    (iii) Narcotic drug supply. A medication unit must receive its 
supply of the narcotic drug directly from the stocks of the primary 
facility. Only persons permitted to administer or dispense the drug or 
security personnel licensed or otherwise authorized by State law to do 
so may deliver the drug to a medication unit.
    (iv) Referral. (A) The patient shall be stabilized at his or her 
optimal dosage level before he or she may be referred to a medication 
unit.
    (B) Since the medication unit does not provide a range of services, 
the program sponsor shall determine that the patient to be referred is 
not in need of frequent counseling, rehabilitative, and other services 
which are only available at the primary program facility.
    (v) Services. A medication unit is limited to administering or 
dispensing a narcotic drug and collecting samples for drug testing or 
analysis for narcotic drugs in accordance with paragraph (d)(2) of this 
section. If a private practitioner wishes to provide other services 
besides administering or dispensing a narcotic drug and collecting 
samples for drug testing or analysis for narcotic drugs, he or she must 
submit an application for separate approval.

[[Page 161]]

    (vi) Responsibility for patient. After a patient is referred to a 
medication unit, the program sponsor retains continuing responsibility 
for the patient's care. The program sponsor shall ensure that the 
patient receives needed medical and rehabilitative services at the 
primary facility.
    (c) Conditions for approval of the use of a narcotic drug in a 
treatment program--(1) Applicants. An individual listed as program 
sponsor for a treatment program using a narcotic drug need not 
personally be a licensed practitioner but shall employ a licensed 
physician for the position of medical director. Persons responsible for 
administering or dispensing the narcotic drug shall be practitioners as 
defined by section 102(21) of the Controlled Substances Act (21 U.S.C. 
802(21)) and licensed to practice by the State in which the program is 
to be established.
    (2)(i) Assent to regulation. A person who sponsors a narcotic 
treatment program, and any persons responsible for a particular program, 
shall agree to adhere to all the rules, directives, and procedures, set 
forth in this section, and any regulation regarding the use of narcotic 
drugs in the treatment of narcotic addiction which may be promulgated in 
the future. The program sponsor has responsibility for all personnel and 
individuals providing services, who work in the program at the primary 
facility or at other facilities or medication units. The program 
sponsors shall agree to inform all personnel and individuals providing 
services of the provisions of this section and to monitor their 
activities to assure compliance with the provisions.
    (ii) The Food and Drug Administration and the State authority are 
required to be notified within 3 weeks of any replacement of the program 
sponsor or medical director. Activities in violation of this regulation 
may give rise to the sanctions set forth in paragraph (i) of this 
section.
    (3) Description of facilities. Only program site(s) approved by 
Federal, State, and local authorities may treat narcotic addicts with a 
narcotic drug. To obtain program approval, the applicant shall 
demonstrate that he or she will have access to adequate physical 
facilities to provide all necessary services. A program must have ready 
access to a comprehensive range of medical and rehabilitative services 
so that the services may be provided when necessary. The name, address, 
and description of each hospital, institution, clinical laboratory, or 
other facility available to provide the necessary services are required 
to be included in the application submitted to the Food and Drug 
Administration and the State authority. The application is also required 
to include the name and address of each medication unit.
    (4) Submission of proper applications. The following applications 
shall be filed simultaneously with both the Food and Drug Administration 
and the State authority:
    (i) Form FDA-2632 ``Application for Approval of Use of Narcotic 
Drugs in a Treatment Program.'' This form, required by paragraph (l) of 
this section, shall be completed and signed by the program sponsor and 
submitted in duplicate to the Food and Drug Administration and the State 
authority.
    (ii) Form FDA-2633 ``Medical Responsibility Statement for Use of 
Narcotic Drugs in a Treatment Program.'' This form, required by 
paragraph (l) of this section, shall be completed and signed by each 
licensed physician authorized to administer or dispense narcotic drugs 
and submitted in duplicate to the Food and Drug Administration and the 
State authority. The names of any other persons licensed by law to 
administer or dispense narcotic drugs working in the program shall be 
listed even if they are not responsible for administering or dispensing 
the drug at the time the application is submitted.
    (5) State and Federal approval, denial, and revocation of approval 
of narcotic treatment programs. (i) The Food and Drug Administration may 
grant approval to a program only after FDA has received notification 
from both the State authority and the Drug Enforcement Administration 
that the program conforms to all pertinent State and Federal 
requirements.
    (ii) The Food and Drug Administration will revoke the approval of a 
narcotic treatment program if so requested by the State authority or the 
Drug Enforcement Administration. If

[[Page 162]]

approval of a program is denied or revoked, the program shall have a 
right to appeal to the Commissioner, as provided for in paragraph (h)(5) 
of this section.
    (iii) No shipment of a narcotic drug may lawfully be made to any 
program which does not have current approval from the Food and Drug 
Administration. Within 60 days after receipt of the application from the 
program sponsor for approval, the Food and Drug Administration will 
notify the sponsor whether the application is approved or denied.
    (d)(1) Minimum standards for admission--(i) History of addiction and 
current physiologic dependence. (A) A person may be admitted as a 
patient for a comprehensive maintenance program only if a program 
physician determines that the person is currently physiologically 
dependent upon a narcotic drug and became physiologically dependent at 
least 1 year before admission for comprehensive maintenance treatment. A 
1-year history of addiction means that an applicant for admission to a 
comprehensive maintenance program was physiologically addicted to a 
narcotic at a time at least 1 year before admission to a program and was 
addicted, continuously or episodically, for most of the year immediately 
before admission to a program. In the case of a person for whom the 
exact date on which physiological addiction began cannot be ascertained, 
the admitting program physician may, in his or her reasonable clinical 
judgment, admit the person to comprehensive maintenance treatment, if 
from the evidence presented, observed, and recorded in the patient's 
record, it is reasonable to conclude that there was physiologic 
dependence at a time approximately 1 year before admission.
    (B) Although daily use of a narcotic for an entire year could 
satisfy the regulatory definition of a 1-year history of addiction, 
operationally one might be physiologically dependent without daily use 
during the entire 1-year period and still satisfy the definition. The 
following, although not exhaustive, are examples of applicants who would 
meet the minimum standard of a 1-year history of addiction and who, if 
currently physiologically dependent on the date of application for 
admission, would be eligible for admission to a comprehensive 
maintenance program:
    (1) Physiologic addiction began in August 1987 and continued to the 
date of application for admission in August 1988.
    (2) Physiologic addiction began in January 1988 and continued until 
April 1988. Physiologic addiction began again in July 1988 and continued 
until the application for admission in January 1989.
    (3) Physiologic addiction began in January 1987 and continued until 
October 1987. The date of application for admission was January 1988, at 
which time the patient had been readdicted for 1 month preceding his or 
her admission.
    (4) Physiologic addiction consisted of four episodes in the last 
year, each episode lasting 2\1/2\ months.
    (C) The program physician or an appropriately trained staff member 
designated and supervised by the physician shall record in the patient's 
record the criteria used to determine the patient's current physiologic 
dependence and history of addiction. In the latter circumstance, the 
program physician shall review, date, and countersign the supervised 
staff member's evaluation to demonstrate his or her agreement with the 
evaluation. The program physician shall make the final determination 
concerning a patient's physiologic dependence and history of addiction. 
The program physician shall sign, date, and record a statement that he 
or she has reviewed all the documented evidence to support a 1-year 
history of addiction and the current physiologic dependence and that in 
his or her reasonable clinical judgment the patient fulfills the 
requirements for admission to comprehensive maintenance treatment. The 
program physician shall complete and record the statement before the 
program administers any narcotic drug to the patient.
    (ii) Voluntary participation, informed consent. The person 
responsible for the program shall ensure that: A patient voluntarily 
chooses to participate in a program; all relevant facts concerning the 
use of the narcotic drug used by the program are clearly and adequately 
explained to the patient; all patients,

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with full knowledge and understanding of its contents, sign the 
``Consent to Treatment with an Approved Narcotic Drug'' Form FDA-2635 
(see paragraph (l) of this section); a parent, legal guardian, or 
responsible adult designated by the State authority (e.g., ``emancipated 
minor'' laws) sign for patients under the age of 18 the second part of 
Form FDA-2635 ``Consent to Treatment with an Approved Narcotic Drug.''
    (iii) Exceptions to minimum admission criteria--(A) Penal or chronic 
care. A person who has resided in a penal or chronic care institution 
for 1 month or longer may be admitted to comprehensive maintenance 
treatment within 14 days before release or discharge, or within 6 months 
after release from such an institution without documented evidence to 
support findings of physiological dependence, provided the person would 
have been eligible for admission before he or she was incarcerated or 
institutionalized and, in the reasonable clinical judgment of a program 
physician, treatment is medically justified. Documented evidence of the 
prior residence in a penal or chronic care institution and evidence of 
all other findings and the criteria used to determine the findings are 
required to be recorded in the patient's record by the admitting program 
physician, or by program personnel supervised by the admitting program 
physician. The admitting program physician shall date and sign these 
recordings or review the health-care professional's recordings before 
the initial dose is administered to the patient. In the latter case, the 
admitting program physician shall date and sign the recordings in the 
patient's record made by the health-care professional within 72 hours of 
administration of the initial dose to the patient.
    (B) Pregnant patients. (1) Pregnant patients, regardless of age, who 
have had a documented narcotic dependency in the past and who may return 
to narcotic dependency, with all its attendant dangers during pregnancy, 
may be placed on a comprehensive maintenance regimen, except as provided 
in paragraph (d)(1)(iii)(B)(6) of this section. For such patients, 
evidence of current physiological dependence on narcotic drugs is not 
needed if a program physician certifies the pregnancy and, in his or her 
reasonable clinical judgment, finds treatment to be medically justified. 
Evidence of all findings and the criteria used to determine the findings 
are required to be recorded in the patient's record by the admitting 
program physician, or by program personnel supervised by the admitting 
program physician. The admitting program physician shall date and sign 
these recordings or review the health-care professional's recordings 
before the initial dose is administered to the patient. In the latter 
case, the admitting program physician shall date and sign the recordings 
in the patient's record made by the health-care professional within 72 
hours of administration of the initial dose to the patient. Pregnant 
patients are required to be given the opportunity for prenatal care 
either by the program or by referral to appropriate health-care 
providers.
    (2) If a program cannot provide direct prenatal care for pregnant 
patients in treatment, the program shall establish a system for 
informing the patients of the publicly or privately funded prenatal care 
opportunities available. If there are no publicly funded prenatal 
referral opportunities and the program cannot provide such services or 
the patient cannot afford them or refuses them, then the treatment 
program shall, at a minimum, offer her basic prenatal instruction on 
maternal, physical, and dietary care as part of its counseling service.
    (3) Counseling records and/or other appropriate patient records are 
required to reflect the nature of prenatal support provided by the 
program. If the patient is referred for prenatal services, the physician 
to whom she is referred is required to be notified that she is in 
comprehensive maintenance treatment, provided that notification is in 
accordance with the Department of Health and Human Services' 
confidentiality regulations (42 CFR part 2). If a pregnant patient 
refuses direct treatment or appropriate referral for treatment, the 
treating program physician should consider using informed consent 
procedures; e.g., to have the patient acknowledge in writing that

[[Page 164]]

she had the opportunity for this treatment but refuses it. The program 
physician, consistent with the confidentiality regulations, shall 
request the physician or the hospital to which a patient is referred to 
provide, following birth, a summary of the delivery and treatment 
outcome for the patient and offspring. If the program physician does not 
receive a response to the request, he or she shall document in the 
record that such a request was made.
    (4) Within 3 months after termination of pregnancy, the program 
physician shall enter an evaluation of the patient's treatment state 
into her record and state whether she should remain in the comprehensive 
maintenance program or be detoxified.
    (5) Caution should be taken in the comprehensive maintenance 
treatment of pregnant patients. Dosage levels should be maintained at 
the lowest effective dose if treatment is deemed necessary. The program 
sponsor shall ensure that each female patient is fully informed of the 
possible risks to her or to her unborn child from continued use of 
illicit drugs and from the use of, or withdrawal from, a narcotic drug 
administered or dispensed by the program in comprehensive maintenance or 
detoxification treatment.
    (6) Patients who are or become pregnant shall not be started or 
continued on LAAM, except by the written order of a physician who 
determines this to be the best choice of therapy for that patient. 
Clinics providing treatment with LAAM must advise all patients of 
childbearing potential of the risks of LAAM and make a medical 
evaluation available to all patients who become pregnant while taking 
the drug. An initial pregnancy test shall be performed for each 
prospective female patient of childbearing potential before admission to 
LAAM comprehensive maintenance treatment and monthly pregnancy tests 
performed thereafter on such female patients in LAAM comprehensive 
maintenance treatment. Analysis of such tests shall be performed in a 
laboratory approved under the Clinical Laboratory Improvement Amendments 
of 1988 or in a laboratory certified by a State or private accrediting 
body approved by the Health Care Financing Administration.
    (C) Previously treated patients. Under certain circumstances a 
patient who has been treated and later voluntarily detoxified from 
comprehensive maintenance treatment may be readmitted to maintenance 
treatment, without evidence to support findings of current physiologic 
dependence, up to 2 years after discharge, if the program attended is 
able to document prior narcotic drug comprehensive maintenance treatment 
of 6 months or more, and the admitting program physician, in his or her 
reasonable clinical judgment, finds readmission to comprehensive 
maintenance treatment to be medically justified. For patients meeting 
these criteria, the quantity of take-home medication, if take-home 
medication is permitted for the narcotic drug, will be determined in the 
reasonable clinical judgment of the program physician, but in no case 
may the quantity of take-home medication be greater than would have been 
allowed at the time the patient voluntarily terminated previous 
treatment. The admitting program physician or a program employee under 
supervision of the admitting program physician must enter in the 
patient's record documented evidence of the patient's prior treatment 
and evidence of all decisions and criteria used relating to the 
admission of the patient and the quantity of take-home medication 
permitted. The admitting program physician shall date and sign these 
entries in the patient's record or review the health-care professional's 
entries therein before the program administers any medication to the 
patient. In the latter case, the admitting program physician shall date 
and sign the entries in the patient's record made by the health-care 
professional within 72 hours of administration of the initial dose to 
the patient.
    (iv) Special limitation; treatment of patients under 18 years of 
age. (A) A person under 18 years of age is required to have had two 
documented attempts at short-term detoxification or drug-free treatment 
to be eligible for maintenance treatment, except as provided in 
paragraph (d)(1)(iv)(B) of this section. A 1-week waiting period is 
required after such a detoxification attempt, however, before an attempt 
is repeated. The program physician shall document

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in the patient's record that the patient continues to be or is again 
physiologically dependent on narcotic drugs. No person under 18 years of 
age may be admitted to a maintenance treatment program unless a parent, 
legal guardian, or responsible adult designated by the State authority 
(e.g., ``emancipated minor'' laws) completes and signs consent form, 
Form FDA-2635 ``Consent to Treatment with an Approved Narcotic Drug.''
    (B) A person under 18 years of age shall not be admitted to LAAM 
maintenance treatment.
    (v) Denial of admission. If in the reasonable clinical judgment of 
the medical director a particular patient would not benefit from 
treatment with a narcotic drug, the patient may be refused such 
treatment even if the patient meets the admission standards.
    (2) Minimum testing or analysis for drugs: Uses and frequency. (i) 
The person(s) responsible for a program shall ensure that: An initial 
drug-screening test or analysis is completed for each prospective 
patient; at least eight additional random tests or analyses are 
performed on each patient during the first year in comprehensive 
maintenance treatment; and at least quarterly random tests or analyses 
are performed on each patient in comprehensive maintenance treatment for 
each subsequent year, except that a random test or analysis is performed 
monthly on each patient who receives a 6-day supply of take-home 
medication. When a sample is collected from each patient for such test 
or analysis, it must be done in a manner that minimizes opportunity for 
falsification. Each test or analysis must be analyzed for opiates, 
methadone, amphetamines, cocaine, and barbiturates. In addition, if any 
other drug or drugs have been determined by a program to be abused in 
that program's locality, or as otherwise indicated, each test or 
analysis must be analyzed for any of those drugs as well. Any laboratory 
that performs the testing required under this regulation shall be in 
compliance with all applicable Federal proficiency testing and licensing 
standards and all applicable State standards. If a program proposes to 
change a laboratory used for such testing or analysis, the program shall 
have the change approved by the Food and Drug Administration.
    (ii) The person responsible for a program shall ensure that test 
results are not used as the sole criterion to force a patient out of 
treatment but are used as a guide to change treatment approaches. The 
person responsible for a program shall also ensure that when test 
results are used, presumptive laboratory results are distinguished from 
results that are definitive.
    (3) Patient evaluation; minimum admission and periodic 
requirements--(i) Minimum contents of medical evaluation. Each patient 
is required to have a medical evaluation by a program physician or an 
authorized health-care professional under the supervision of a program 
physician on admission to a program. At a minimum, this evaluation is 
required to consist of a medical history which includes the required 
history of narcotic dependence, evidence of current physiologic 
dependence unless excepted by the regulations, and a physical 
examination, and includes the following laboratory examinations: 
serological test for syphilis, a tuberculin skin test, and a test or 
analysis for drug determination. A pregnancy test is required for any 
woman of childbearing potential before she may be administered LAAM as 
directed in paragraph (d)(1)(iii)(B)(1) of this section. If in the 
reasonable clinical judgment of the program physician, a patient's 
subcutaneous veins are severely damaged to the extent that a blood 
specimen cannot be obtained, the serological test for syphilis may be 
omitted. The physical examination is required to consist of an 
investigation of the organ systems for possibilities of infectious 
disease, pulmonary, liver, and cardiac abnormalities, and dermatologic 
sequelae of addiction. In addition, the physical examination is required 
to include a determination of the patient's vital signs (temperature, 
pulse, and blood pressure and respiratory rate); an examination of the 
patient's general appearance, head, ears, eyes, nose, throat (thyroid), 
chest (including heart, lungs, and breasts), abdomen, extremities, skin, 
and neurological assessment; and the program physician's overall 
impression of the patient.

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    (ii) Recordings of findings. The admitting program physician or an 
appropriately trained health care professional supervised by the 
admitting program physician shall record in the patient's record all 
findings from the admission medical evaluation. In each case the 
admitting program physician shall date and sign these entries, or date, 
review, and countersign these recordings in the patient's record to 
signify his or her review of and concurrence with the history and 
physical findings.
    (iii) Admission evaluation. (A) Each patient seeking admission or 
readmission for treatment services is required to be interviewed by a 
well-trained program counselor, qualified by virtue of education, 
training, or experience to assess the psychological and sociological 
background of drug abusers, to determine the appropriate treatment plan 
for the patient. To determine the most appropriate treatment plan for a 
patient, the interviewer shall obtain and document in the patient's 
record the patient's history.
    (B) A patient's history includes information relating to his or her 
educational and vocational achievements. If a patient has no such 
history; i.e., he or she has no formal education or has never had an 
occupation, this requirement is met by writing this information in the 
patient's history.
    (iv) Initial treatment plan. (A)(1) The initial treatment plan is 
required to contain a statement that outlines realistic short-term 
treatment goals which are mutually acceptable to the patient and the 
program. The initial treatment plan is also required to spell out the 
behavioral tasks a patient must perform to complete each short-term 
goal; the patient's requirements for education, vocational 
rehabilitation, and employment; and the medical, psychosocial, economic, 
legal, or other supportive services that a patient needs. The plan is 
also required to identify the frequency with which these services are 
likely to be provided. Prior to developing a treatment plan, the 
patient's needs for medical, social, and psychological services; 
education; vocational rehabilitation; and employment must be assessed, 
and the needs reflected, when clinically appropriate, in the treatment 
plan.
    (2) A primary counselor is one who is assigned by the program to 
develop, implement, and evaluate the patient's initial and periodic 
treatment plan and to monitor a patient's progress in treatment. The 
primary counselor shall enter in the patient's record the counselor's 
name, the contents of a patient's initial assessment, and the initial 
treatment plan. The primary counselor shall make these entries 
immediately after the patient is stabilized on a dose or within 4 weeks 
after admission, whichever is sooner.
    (B) It is recognized that patients need varying degrees of treatment 
and rehabilitative services which are often dependent on or limited by a 
number of variables; e.g., patient resources, available program, and 
community services. It is not the intent of this regulation to prescribe 
a particular treatment and rehabilitative service or the frequency at 
which a service should be offered.
    (C) The program supervisory counselor or other appropriate program 
personnel so designated by the program physician shall review and 
countersign all the information and findings required to be recorded in 
each patient's record under paragraph (d)(3)(iv) of this section.
    (v) Periodic treatment plan evaluation. (A) The program physician or 
the primary counselor shall review, reevaluate, and alter where 
necessary each patient's treatment plan at least once each 90 days 
during the first year of treatment, and then at least twice a year after 
the first year of continuous treatment.
    (B) The program physician shall ensure that the periodic treatment 
plan becomes part of each patient's record and that it is signed and 
dated in the patient's record by the primary counselor and is 
countersigned and dated by the supervisory counselor.
    (C) At least once a year, the program physician shall date, review, 
and countersign the treatment plan recorded in each patient's record and 
ensure that each patient's progress or lack of progress in achieving the 
treatment goals is entered in the patient's record by the primary 
counselor. When appropriate, the treatment plan and progress

[[Page 167]]

notes should deal with the patient's mental and physical problems, apart 
from drug abuse. The treatment plan is required to include the name of 
and the reasons for prescribing any medication for emotional or physical 
problems.
    (D) The requirement for annual physician review and signature by the 
program physician in paragraph (d)(3)(v)(C) of this section is 
discretionary, however, as it applies to a patient who has 
satisfactorily adhered to program rules for at least 3 consecutive years 
from his or her entrance into the comprehensive maintenance treatment 
program and who has made substantial progress in rehabilitation.
    (4) Minimum program services--(i)(A) Access to a range of services. 
A treatment program shall provide a comprehensive range of medical and 
rehabilitative services to its patients especially during the first 3 
years of treatment.
    (B) Pregnant patients. (1) For pregnant patients in a treatment 
program who were not admitted under paragraph (d)(1)(iii)(B) of this 
section, a treatment program shall give them the opportunity for 
prenatal care either by the narcotic treatment program or by referral to 
appropriate health care providers. If a program cannot provide direct 
prenatal care for pregnant patients in treatment, it shall establish a 
system of referring them for prenatal care which may be either publicly 
or privately funded. If there is no publicly funded prenatal care 
available to which a patient may be referred, and the program cannot 
provide such services, or the patient cannot afford or refuses prenatal 
care services, then the treatment program shall, at a minimum, offer her 
basic prenatal instruction on maternal, physical, and dietary care as a 
part of its counseling service.
    (2) Counseling records and other appropriate patient records are 
required to reflect the nature of prenatal support provided by the 
program. If the program refers a patient for prenatal services, it shall 
inform the physician to whom she is referred that the patient is in 
comprehensive maintenance treatment, provided such notification is in 
accordance with the Department of Health and Human Services' 
confidentiality regulations (42 CFR part 2). If a pregnant patient 
refuses direct prenatal services or appropriate referral for prenatal 
services, the treating program physician should consider using informed 
consent procedures; i.e., to have the patient acknowledge in writing 
that she has the opportunity for this treatment but refuses it. The 
program physician shall request the physician or the hospital to which a 
patient is referred to provide, following birth, a summary of the 
delivery and treatment outcome for the patient and offspring. The 
information should be obtained in accordance with the Department of 
Health and Human Services' confidentiality regulations (42 CFR part 2). 
If no response is received, the program physician shall document in the 
record that such a request was made and no response was received.
    (3) Caution should be taken in the maintenance treatment of pregnant 
patients. Dosage levels should be maintained at the lowest effective 
dose if continued treatment is deemed necessary. It is the 
responsibility of the program sponsor to ensure that each female patient 
is fully informed of the possible risks to a pregnant woman and her 
unborn child from continued use of illicit drugs and from the use of, or 
withdrawal from, a narcotic drug administered or dispensed by the 
program in maintenance or detoxification treatment.
    (C) Counseling on HIV disease. A narcotic treatment program shall 
provide counseling on preventing exposure to, and the transmission of, 
HIV disease for each patient admitted or readmitted to maintenance or 
detoxification treatment. Although HIV testing is not required, an 
interim program shall inform patients of the availability of HIV 
testing. The program sponsor shall also ensure that HIV testing is 
accessible to patients who request such testing either on site or by the 
programs entering into agreements with HIV testing facilities to make 
HIV testing accessible to those patients who request it.
    (D) Off-site services. Any service not furnished at the primary 
facility is required to be listed in any application for approval 
submitted to the Food and Drug Administration or to the State authority. 
The addition, modification,

[[Page 168]]

or deletion of any program service is required to be reported 
immediately to the Food and Drug Administration.
    (ii) Minimum medical services; designation of medical director and 
responsibilities. Each program shall have a designated medical director 
who assumes responsibility for administering all medical services 
performed by the program. The medical director and other authorized 
program physicians are required to be licensed to practice medicine in 
the jurisdiction in which the program is located. The medical director 
is responsible for ensuring that the program is in compliance with all 
Federal, State, and local laws and regulations regarding medical 
treatment of narcotic addiction. In addition, the medical director or 
other authorized physicians shall:
    (A) Ensure that evidence of current physiologic dependence, length 
of history of addiction, or exceptions to criteria for admission are 
documented in the patient's record before the patient receives the 
initial dose.
    (B) Ensure that a medical evaluation including a medical history has 
been taken, and physical examination has been done before the patient 
receives the initial dose (except that in an emergency situation, the 
initial dose may be given before the physical examination).
    (C) Ensure that appropriate laboratory studies have been performed 
and reviewed.
    (D) Sign or countersign all medical orders as required by Federal or 
State law. (Such medical orders include but are not limited to the 
initial medication orders and all subsequent medication order changes, 
all changes in the frequency of take-home medication, and prescribing 
additional take-home medication for an emergency situation.)
    (E) Review and countersign treatment plans at least annually as 
qualified by paragraph (d)(3)(v)(D) of this section.
    (F) Ensure that justification is recorded in the patient's record 
for reducing the frequency of clinic visits for observed drug ingesting, 
providing additional take-home medication under exceptional 
circumstances or when there is physicial disability, or prescribing any 
medication for physical or emotional problems.
    (iii) Use of health-care professionals. Although the final decision 
to accept a patient for treatment may be made only by the medical 
director or other designated program physician, it is recognized that 
physicians can train program personnel to detect and document narcotic 
abstinence symptons and that some jurisdictions allow State-licensed or 
certified health-care professionals; e.g., physician's assistants, nurse 
practitioners, to perform certain functions--record medical histories, 
perform physicial examinations, and prescribe, administer, or dispense 
certain medications--that are ordinarily performed by a licensed 
physician. These regulations do not prohibit licensed or certified 
health-care professionals from performing those functions in narcotic 
treatment programs if it is authorized by Federal, State, and local laws 
and regulations, and if those functions are delegated to them by the 
medical director, and records are properly countersigned by the medical 
director or a licensed physician.
    (iv) Vocational rehabilitation, education, and employment. Each 
program shall provide opportunities directly, or through referral to 
community resources, for patients who either desire or have been deemed 
by the program staff to be ready to participate in educational job 
training programs or to obtain gainful employment as soon as possible.
    (v) Authorized dispensers of narcotic drugs; responsibility. A 
narcotic drug may be administered or dispensed only by a practitioner 
licensed under the appropriate State law and registered under the 
appropriate State and Federal laws to order narcotic drugs for patients, 
or by an agent of such a practitioner, supervised by and under the order 
of the practitioner. This agent is required to be a pharmacist, 
registered nurse, or licensed practical nurse, or any other health care 
professional authorized by Federal and State law to administer or 
dispense narcotic drugs. The licensed practitioner assumes 
responsibility for the amounts of narcotic drugs administered or 
dispensed and shall record and countersign all changes in dosage 
schedule.

[[Page 169]]

    (5) Staffing patterns--(i) Program personnel. The person(s) 
responsible for a program shall determine program personnel requirements 
after considering the number of patients who are vocationally and 
educationally impaired; the number of patients with significant 
psychopathology; the number of patients who are also nonnarcotic drug or 
alcohol abusers; the number of patients with behavioral problems in the 
program; and the number of patients with serious medical problems.
    (ii) Supportive services. The person(s) responsible for the program 
shall take notice, when considering the staffing pattern, that 
comprehensive maintenance treatment programs need to establish 
supportive services in accordance with the varying characteristics and 
needs of their patient populations. The person(s) responsible for a 
program shall also take notice of the availability of existing community 
resources which may complement or enhance the program's delivery of 
supportive services and then establish a staffing pattern based on a 
combination of patient needs and available, accessible community 
resources.
    (6) Use of methadone in a treatment program; frequency of 
attendance; quantity of take-home medication; dosage of methadone; 
initial and stabilization--(i) Dosage and responsibility. (A) The 
person(s) responsible for the program shall ensure that the initial dose 
of methadone does not exceed 30 milligrams and that the total dose for 
the first day does not exceed 40 milligrams, unless the program medical 
director documents in the patient's record that 40 milligrams did not 
suppress opiate abstinence symptoms.
    (B) A licensed physician shall assume responsibility for the amount 
of the narcotic drug administered or dispensed and shall record, date, 
and sign in each patient's record each change in the dosage schedule.
    (C) The administering licensed physician shall ensure that a daily 
dose greater than 100 milligrams is justified in the patient's record.
    (ii) [Reserved]
    (iii) Form. Methadone may be administered or dispensed in oral form 
only when used in a treatment program. Hospitalized patients under care 
for a medical or surgical condition are permitted to receive methadone 
in parenteral form when the attending physician judges it advisable. 
Although tablet, syrup concentrate, or other formulations may be 
distributed to the program, all oral medication is required to be 
administered or dispensed in a liquid formulation. The oral dosage form 
is required to be formulated in such a way as to reduce its potential 
for parenteral abuse. Take-home medication is required to be labeled 
with the treatment center's name, address, and telephone number and must 
be packaged in special packaging as required by 16 CFR 1700.14 in 
accordance with the Poison Prevention Packaging Act (Pub. L. 91-601, 15 
U.S.C. 1471 et seq.) to reduce the chances of accidental ingestion. 
Exceptions may be granted when these provisions conflict with State law 
with regard to the administering or dispensing of drugs.
    (iv) Take-home medication. (A) Take-home medication may be given 
only to a patient who, in the reasonable clinical judgment of the 
program physician, is responsible in handling narcotic drugs. Before the 
program physician reduces the frequency of a patient's clinical visits, 
she or he or a designated staff member shall record the rationale for 
the decision in the patient's clinical record. If this is done by a 
designated staff member, a program physician shall review, countersign, 
and date the patient's record where this information is recorded.
    (B) The program physician shall consider the following in 
determining whether, in his or her reasonable clinical judgment, a 
patient is responsible in handling narcotic drugs:
    (1) Absence of recent abuse of drugs (narcotic or nonnarcotic), 
including alcohol;
    (2) Regularity of clinic attendance;
    (3) Absence of serious behavioral problems at the clinic;
    (4) Absence of known recent criminal activity, e.g., drug dealing;
    (5) Stability of the patient's home environment and social 
relationships;
    (6) Length of time in comprehensive maintenance treatment;
    (7) Assurance that take-home medication can be safely stored within 
the patient's home; and

[[Page 170]]

    (8) Whether the rehabilitative benefit to the patient derived from 
decreasing the frequency of clinic attendance outweighs the potential 
risks of diversion.
    (v) Take-home requirements. The requirement of time in treatment is 
a minimum reference point after which a patient may be eligible for 
take-home privileges. The time reference is not intended to mean that a 
patient in treatment for a particular time has a specific right to take-
home medication. Thus, regardless of time in treatment, a program 
physician may, in his or her reasonable judgment, deny or rescind the 
take-home medication privileges of a patient.
    (A)(1) In comprehensive maintenance treatment it is required that a 
patient come to the clinic for observation daily or at least 6 days a 
week. If, in the reasonable clinical judgment of the program physician, 
a patient demonstrates that he or she has satisfactorily adhered to 
program rules for at least 3 months, has made substantial progress in 
rehabilitation and responsibility in handling narcotic drugs (see 
paragraphs (d)(6)(iv)(B) (1) through (8) of this section, and would 
improve his or her rehabilitative progress by decreasing the frequency 
of attendance at the clinic for observation, the patient may be 
permitted to reduce his or her attendance at the clinic for observation 
to three times weekly. The patient may receive no more than a 2-day 
take-home supply of medication.
    (2) If, in the reasonable clinical judgment of the program 
physician, a patient demonstrates that he or she has satisfactorily 
ahered to program rules for at least 2 years from his or her entrance 
into the program, has made substantial progress in rehabilitation and 
responsibility in handling narcotic drugs (see paragraphs (d)(6)(iv)(B) 
(1) through (8) of this section), and would improve his or her 
rehabilitative progress by decreasing the frequency of attendance at the 
clinic for observation, the patient may be permitted to reduce his or 
her clinic attendance at the clinic for observation to twice weekly. 
Such a patient may receive no more than a 3-day take-home supply of 
medication.
    (3) If, in the reasonable clinical judgment of the program 
physician, a patient demonstrates that he or she has satisfactorily 
adhered to program rules for at least 3 consecutive years from his or 
her entrance into the comprehensive maintenance treatment program, has 
made substantial progress in rehabilitation, has no major behavioral 
problems, is responsible in handling narcotic drugs (see paragraphs 
(d)(6)(iv)(B) (1) through (8) of this section), and would improve his or 
her rehabilitative progress by decreasing the frequency of his or her 
clinic attendance for observation, the patient may be permitted to 
reduce clinic attendance for observation to once weekly, provided that 
the following additional criteria are met: The program physician has 
written into the patient's record an evaluation that the patient is 
responsible in handling narcotic drugs (paragraphs (d)(6)(iv)(B) (1) 
through (8) of this section); the patient is employed (or actively 
seeking employment), attends school, is a homemaker, or is considered 
unemployable for mental or physical reasons by a program physician; the 
patient is not known to have abused drugs including alcohol in the last 
year; and the patient is not known to have engaged in criminal activity; 
e.g., drug dealing, in the last year. A patient permitted to reduce 
clinic attendance for observation to once weekly may receive no more 
than a 6-day take-home supply of medication.
    (B)(1) If a patient, after receiving a supply of take-home 
medication, is inexcusably absent from or misses a scheduled appointment 
with a treatment program without authorization from the program staff, 
the program physician shall increase the frequency of the patient's 
clinic attendance for drug ingestion under observation. For such a 
patient, the program physician shall not reduce the frequency of the 
patient's clinic attendance for drug ingestion under observation until 
she or he has had at least three consecutive monthly tests or analyses 
that are neither positive for morphine-like drugs (except from the 
narcotic drug administered or dispensed by the program) or other drugs 
of abuse, nor negative for the narcotic drug administered or dispensed 
by the program, and until she or he is again determined by a program

[[Page 171]]

physician to be responsible in handling narcotic drugs (see paragraphs 
(d)(6)(iv)(B) (1) through (8) of this section) and to meet criteria in 
paragraph (d)(6)(v)(A) of this section.
    (2) If a patient, after receiving a 6-day supply of take-home 
medication, has a test or analysis which is confirmed to be positive for 
morphine-like drugs (except for the narcotic drug administered or 
dispensed by the program) or other drugs of abuse, or negative for the 
narcotic drug administered or dispensed by the program, the program 
physician shall place the patient on probation for 3 months. If, during 
this probation, the patient has a test or analysis either positive for 
morphine-like drugs (except for the narcotic drug administered or 
dispensed by the program) or other drugs of abuse, or negative for the 
narcotic drug administered or dispensed by the program, the program 
physician shall increase the frequency of the patient's clinic 
attendance for observation to at least twice weekly. Such a patient may 
receive no more than a 3-day take-home supply of medication until she or 
he has had at least three consecutive monthly tests or analyses which 
are neither positive for morphine-like drugs (except for the narcotic 
drug administered or dispensed by the program) or other drugs of abuse, 
nor negative for the narcotic drug administered or dispensed by the 
program, and the program physician again determines that the patient is 
responsible in handling narcotic drugs (see paragraphs (d)(6)(iv)(B) (1) 
through (8) of this section) and meets the criteria contained in 
paragraph (d)(6)(v)(A) of this section.
    (C) In calculating the number of years of comprehensive maintenance 
treatment, the period is considered to begin on the first day the 
medication is administered, or on readmission if a patient has had a 
continuous absence of 90 days or more. Cumulative time spent by the 
patient in more than one program is counted toward the number of years 
of treatment, provided there has not been a continuous absence of 90 
days or more.
    (D) Each patient whose daily dose is above 100 milligrams is 
required to be under observation while ingesting the drug at least 6 
days per week irrespective of the length of time in treatment, unless 
the program has received prior approval from the Food and Drug 
Administration with the concurrence of the State authority.
    (vi) Exceptions to take-home requirements. If, in the reasonable 
clinical judgment of the program physician:
    (A) A patient is found to have a physical disability which 
interferes with his or her ability to conform to the applicable 
mandatory schedule, she or he may be permitted a temporarily or 
permanently reduced schedule, provided she or he is also found to be 
responsible in handling narcotic drugs.
    (B) A patient, because of exceptional circumstances such as illness, 
personal or family crises, travel, or other hardship, is unable to 
conform to the applicable mandatory schedule, she or he may be permitted 
a temporarily reduced schedule, provided she or he is also found to be 
responsible in handling narcotic drugs. The rationale for an exception 
to a mandatory schedule is to be based on the reasonable clinical 
judgment of the program physician and shall be recorded in the patient's 
record by the program physician or by program personnel supervised by 
the program physician. In the latter situation, the physician shall 
review, countersign, and date the patient's record where this rationale 
is recorded. In any event, a patient may not be given more than a 2-week 
supply of narcotic drugs at one time.
    (vii) Official State holidays. If a treatment center program is not 
in operation due to the observance of an official State holiday, 
patients may be permitted one extra take-home dose per visit and one 
fewer clinic visit per week to allow patients not to have to attend the 
clinic on an official State holiday. An official State holiday is a 
holiday on which most State offices are usually closed and routine State 
government business is not conducted.
    (7) Minimum standards for interim maintenance treatment. The 
person(s) responsible for a program may place an individual, who is 
eligible for admission to comprehensive maintenance treatment, in 
interim maintenance treatment if the individual cannot be placed in a 
public or nonprofit private

[[Page 172]]

comprehensive program within a reasonable geographic area and within 14 
days of the individual's application for admission. An initial and at 
least two other urine screens shall be taken from interim patients 
during the maximum of 120 days permitted for such treatment. A program 
shall establish and follow reasonable criteria for establishing 
priorities for transferring patients from interim maintenance to 
comprehensive maintenance treatment. These transfer criteria shall be in 
writing and available for inspection and shall include, at a minimum, a 
preference for pregnant women in admitting patients to interim 
maintenance and in transferring patients from interim maintenance to 
comprehensive maintenance treatment. Interim maintenance shall be 
provided in a manner consistent with all applicable Federal and State 
laws including sections 1923 (mandatory transfer) and 1927(a) (pregnant 
patients) of the PHS Act. The program shall notify the State health 
officer when a patient begins interim treatment, when a patient leaves 
interim treatment, and before the date of mandatory transfer to a 
comprehensive program, and shall document such notifications. Programs 
in States not in compliance with provisions of this regulation risk loss 
of authorization for interim maintenance. All requirements for 
comprehensive maintenance treatment apply to interim maintenance 
treatment with the following exceptions:
    (i) The narcotic drug is required to be administered daily under 
observation;
    (ii) Take-home medication is not allowed;
    (iii) The initial treatment plan and periodic treatment plan 
evaluation are not required;
    (iv) A primary counselor is not required to be assigned to a 
patient;
    (v) Interim maintenance cannot be provided for longer than 120 days 
in any 12 month-period; and
    (vi) The requirements and exceptions in paragraphs (b)(2)(iii) (as 
apply to rehabilitative services), in paragraphs (b)(3)(iv)(B) and 
(d)(4)(i)(A) (as apply to rehabilitative services), and in paragraphs 
(d)(4)(ii)(E), (d)(4)(ii)(F), (d)(4)(iv), (d)(6)(iv), (d)(6)(v), 
(d)(6)(vi), and (d)(6)(vii) of this section do not apply.
    (8) Minimum standards for short-term detoxification treatment. (i) 
For short-term detoxification from narcotic drugs, the narcotic drug is 
required to be administered by the program physician or by an authorized 
agent of the physician, supervised by and under the order of the 
physician. The narcotic drug is required to be administered daily, under 
close observation, in reducing dosages over a period not to exceed 30 
days. All requirements for comprehensive maintenance treatment apply to 
short-term detoxification treatment with the following exceptions:
    (A) Take-home medication is not allowed during short-term 
detoxification.
    (B) A history of 1 year physiologic dependence is not required for 
admission to short-term detoxification.
    (C) Patients who have been determined by the program physician to be 
currently physiologically narcotic dependent may be placed in short-term 
detoxification treatment, regardless of age.
    (D) No test or analysis is required except for the initial drug 
screening test or analysis.
    (E) The initial treatment plan and periodic treatment plan 
evaluation required for comprehensive maintenance patients are not 
necessary for short-term detoxification patients. However, a primary 
counselor must be assigned by the program to monitor a patient's 
progress toward the goal of short-term detoxification and possible drug-
free treatment referral.
    (F) The requirements of paragraph (d)(4) of this section, except 
paragraphs (d)(4)(i)(C), (d)(4)(ii)(A) through (d)(4)(ii)(D), and 
(d)(4)(iii) of this section, do not apply to short-term detoxification 
treatment.
    (ii) A patient is required to wait at least 7 days between 
concluding a short-term detoxification treatment episode and beginning 
another. Before a short-term detoxification attempt is repeated, the 
program physician shall document in the patient's record that the 
patient continues to be, or is again, physiologically dependent on 
narcotic

[[Page 173]]

drugs. The provisions of these requirements, except as noted in 
paragraph (d)(8)(i) of this section, apply to both inpatient and 
ambulatory short-term detoxification treatment.
    (iii) Short-term detoxification treatment is not recommended for a 
pregnant patient.
    (9) Minimum standards for long-term detoxification treatment. (i) 
For long-term detoxification from narcotic drugs, the narcotic drug is 
required to be administered by the program physician or by an authorized 
agent of the physician, supervised by and under the order of the 
physician. The narcotic drug is required to be administered on a regimen 
designed to reach a drug-free state and to make progress in 
rehabilitation in 180 days or less. All requirements for comprehensive 
maintenance treatment apply to long-term detoxification treatment with 
the following exceptions.
    (A) In long-term detoxification treatment it is required that the 
patient be under observation while ingesting the drug daily or at least 
6 days a week, for the duration of the long-term detoxification 
treatment.
    (B) A history of 1 year physiologic dependence is not required for 
admission to long-term detoxification.
    (C) The program physician shall document in the patient's record 
that short-term detoxification is not a sufficiently long enough 
treatment course to provide the patient with the additional program 
services he or she deems necessary for the patient's rehabilitation. The 
program physician shall document this information in the patient's 
record before long-term detoxification may begin.
    (D) Patients who have been determined by the program physician to be 
currently physiologically dependent on narcotics may be placed in long-
term detoxification treatment, regardless of age.
    (E) An initial drug screening test or analysis is required for each 
patient. And at least one additional random test or analysis must be 
performed monthly on each patient during long-term detoxification.
    (F) The initial treatment plan and periodic treatment plan 
evaluation required for comprehensive maintenance patients are also 
required for long-term detoxification patients, except that the required 
periodic treatment plan evaluation is required to occur monthly.
    (ii) A patient is required to wait at least 7 days between 
concluding a long-term treatment episode and beginning another. Before a 
long-term detoxification attempt is repeated, the program physician 
shall document in the patient's record that the patient continues to be 
or is again physicologically dependent on narcotic drugs. The provisions 
of these requirements apply to both inpatient and ambulatory long-term 
detoxification treatment.
    (iii) Long-term detoxification is not recommended for a pregnant 
patient.
    (10) Inspections of programs; patient confidentiality. A program 
shall allow inspections by duly authorized employees of the State 
authority, and in accordance with Federal controlled substances laws and 
Federal confidentiality laws, by duly authorized employees of the Food 
and Drug Administration, the Drug Enforcement Administration of the 
Department of Justice, and the National Institute on Drug Abuse.
    (11) Exemptions from specific program standards. (i) A program is 
permitted, at the time of application or any time thereafter, to request 
exemption from specific program standards. The rationale for an 
exemption shall be thoroughly documented in an appendix to be submitted 
with the application or at some later time. The Food and Drug 
Administration will approve such exemptions of program standards at the 
time of application, or any time thereafter, with the concurrence of the 
State authority. An example of a case in which an exemption might be 
granted would be for a private practitioner who wishes to treat a 
limited number of patients in a nonmetropolitan area with few physicians 
and no rehabilitative services geographically accessible and requests 
exemption from some of the staffing and service standards.
    (ii) The Food and Drug Administration has the right to withhold the 
granting of an exemption requested at the time of application until a 
program is in actual operation in order to assess

[[Page 174]]

if the exemption is necessary. If periodic inspections of the progam 
reveal that discrepancies or adverse conditions exist, the Food and Drug 
Administration shall reserve the right to revoke any or all exemptions 
previously granted.
    (12) Research. When a program conducts research on human subjects or 
provides subjects for research, there must be written policies and 
written review to assure the rights of the patients involved. 
Appropriate informed consent forms are required to be signed by the 
patient and to be retained in his or her patient record at the program. 
All research, development, and related activities which involve human 
subjects and which are funded by grants from or contracts with the 
Department of Health and Human Services are required to comply with the 
Department of Health and Human Services' regulations on the protection 
of human subjects, 45 CFR part 46, and confidentiality of information, 
42 CFR part 2. All investigational research involving human subjects 
conducted for submission to the Food and Drug Administration must be 
conducted in compliance with part 312 of this chapter.
    (13) Patient record system--(i) Patient care. The person(s) 
responsible for a program shall establish a record system to document 
and monitor patient care. This system is required to comply with all 
Federal and State reporting requirements relevant to narcotic drugs 
approved for use in treatment of narcotic addiction. All records are 
required to be kept confidential and in accordance with all applicable 
Federal and State regulations regarding confidentiality.
    (ii) Drug dispensing. The person(s) responsible for a program shall 
ensure that accurate records traceable to specific patients are 
maintained showing dates, quantity, and batch or code marks of the drug 
dispensed. These records must be retained for a period of 3 years from 
the date of dispensing.
    (iii) Patient's record. An adequate record must be maintained for 
each patient. The record is required to contain a copy of the signed 
consent form(s), the date of each visit, the amount of drug administered 
or dispensed, the results of each test or analysis for drugs, any 
significant physical or psychological disability, the type of 
rehabilitative and counseling efforts employed, an account of the 
patient's progress, and other relevant aspects of the treatment program. 
For recordkeeping purposes, if a patient misses appointments for 2 weeks 
or more without notifying the program, the episode of care is considered 
terminated and is to be so noted in the patient's record. This does not 
mean that the patient cannot return for care. If the patient does return 
for care and is accepted into the program, this is considered a 
readmission and is to be so noted in the patient's record. This method 
of recordkeeping helps assure the easy detection of sporadic attendance 
and decreases the possibility of administering inappropriate doses of 
narcotic drugs (e.g., the patient who has received no medication for 
several days or more and upon return receives the usual stabilization 
dose). An annual evaluation of the patient's progress must be entered in 
the patient's record.
    (14) Security of drug stocks. adequate security is required to be 
maintained over drug stocks, over the manner in which it is administered 
or dispensed, over the manner in which it is distributed to medication 
units, and over the manner in which it is stored to guard against theft 
and diversion of the drug. The program is required to meet the security 
standards for the distribution and storage of controlled substances as 
required by the Drug Enforcement Administration, Department of Justice 
(21 CFR 1301.72-1301.76).
    (e) Multiple enrollments--(1) Administering or dispensing to 
patients enrolled in other programs. There is a danger of drug dependent 
persons attempting to enroll in more than one narcotic treatment program 
to obtain quantities of drugs for the purpose of self-administration or 
illicit marketing. Therefore, except in an emergency situation, drugs 
shall not be provided to a patient who is known to be currently 
receiving drugs from another treatment program
    (2) Patient attendance requirements. The patient shall always report 
to the same treatment facility unless prior approval is obtained from 
the program

[[Page 175]]

sponsor for treatment at another program. Permission to report for 
treatment at the facility of another program shall be granted only in 
exceptional circumstances and shall be noted on the patient's clinical 
record.
    (f) Conditions for use of narcotic drugs in hospitals for 
detoxification treatment--(1) Form. The drug may be administered or 
dispensed in either oral or parenteral form. (See paragraph (d)(6)(iii) 
of this section.)
    (2) Use of narcotic drugs in hospitals--(i) Approved uses. For 
hospitalized patients, the use of a narcotic drug for narcotic addict 
treatment may be administered or dispensed only for detoxification 
treatment. If a narcotic drug is administered for treatment of narcotic 
dependence for more than 180 days, the procedure is no longer considered 
detoxification but is, rather, considered maintenance treatment. Only 
approved narcotic treatment programs may undertake maintenance 
treatment. This does not preclude the maintenance treatment of a patient 
who is hospitalized for treatment of medical conditions other than 
addiction and who requires temporary maintenance treatment during the 
critical period of his or her stay or whose enrollment in a program 
which has approval for maintenance treatment using narcotic drugs has 
been verified. (See 21 CFR 1306.07(c).) Any hospital which already has 
received approval under this paragraph (f) may serve as a temporary 
narcotic treatment program when an approved treatment program has been 
terminated and there is no other facility immediately available in the 
area to provide narcotic drug treatment for the patients. The Food and 
Drug Administration may give this approval upon the request of the State 
authority or the hospital, When no State authority has been established.
    (ii) Individuals responsible for supplies. Hospitals shall submit to 
the Food and Drug Administration and the State authority the name of the 
individual (e.g., pharmacist) responsible for receiving and securing 
supplies of narcotic drugs for the treatment of narcotic addicts. The 
individual responsible for supplies shall ensure that the only persons 
who receive supplies of narcotic drugs are those who are authorized to 
do so by Federal or State law.
    (iii) General description. The hospital shall submit to the Food and 
Drug Administration and the State authority a general description of the 
hospital including the number of beds, specialized treatment facilities 
for drug dependence, and nature of patient care undertaken.
    (iv) Anticipated quantity of drug needed. The hospital shall submit 
to the Food and Drug Administration and the State authority the 
anticipated quantity of narcotic drugs for narcotic addict treatment 
needed per year.
    (v) Records. The hospital shall maintain accurate records showing 
dates, quantity, and batch or code marks of the drug used for inpatient 
treatment. The hospital shall retain the records for at least a period 
of 3 years.
    (vi) Inspection. The hospital shall permit the Food and Drug 
Administration and the State authority to inspect supplies of the drug 
at the hospital and evaluate the uses to which the drug is being put. 
The Food and Drug Administration and the State authority will keep the 
identity of the patients confidential in accordance with confidentiality 
requirements of 42 CFR part 2. Records on the receipt, storage, and 
distribution of narcotic medication are subject to inspection under 
Federal controlled substances laws; but use or disclosure of records 
identifying patients will, in any case, be limited to actions involving 
the program or its personnel.
    (vii) Approval of hospital pharmacy. Application for a hospital 
pharmacy to provide narcotic drugs for detoxification treatment must be 
submitted to the Food and Drug Administration and the State authority 
and approval from both is required, except as provided for in paragraph 
(h)(5) of this section. Within 60 days after the Food and Drug 
Administration receives the application, it will notify the applicant of 
approval or denial or will request additional information, when 
necessary.
    (viii) Approval of shipments to hospital pharmacies. Before a 
hospital pharmacy may lawfully receive shipments of narcotic drugs for 
detoxification treatment, a responsible official shall complete, sign, 
and file in duplicate with

[[Page 176]]

the Food and Drug Administration and the State authority Form FDA-2636 
``Hospital Request for Methadone Detoxification Treatment'' (see 
paragraph (l) of this section) and must have received from the Food and 
Drug Administration a notice that the request has been approved.
    (ix) Sanctions. Failure to abide by the requirements described in 
this section may result in revocation of approval to receive shipments 
of narcotic drugs for narcotic addict treatment, seizure of the drug 
supply on hand, injunction, and criminal prosecution.
    (g) Confidentiality of patient records. (1) Except as provided in 
paragraph (g)(2) of this section, disclosure of patient records 
maintained by any program is governed by the provisions of 42 CFR part 
2, and every program must comply with that part. Records on the receipt, 
storage, and distribution of narcotic medication are also subject to 
inspection under Federal controlled substances laws: But use or 
disclosure of records identifying patients will, in any case, be limited 
to actions involving the program or its personnel.
    (2) A treatment program or medication unit or any part thereof, 
including any facility or any individual, shall permit a duly authorized 
employee of the Food and Drug Administration to have access to and to 
copy all records on the use of narcotic drugs in accordance with the 
provisions of 42 CFR part 2. A treatment program may reveal such records 
only when necessary in a related administrative or court proceeding.
    (h) Denial or revocation of approval. (1) Complete or partial denial 
or revocation of approval of an application to receive shipments of 
narcotic drugs (Forms FDA-2632 ``Application for Approval of Use of 
Narcotic Drugs in a Treatment Program'' and FDA-2636 ``Hospital Request 
for Methadone Detoxification Treatment'') may be proposed to the 
Commissioner of Food and Drugs by the Director of the Food and Drug 
Administration's Center for Drug Evaluation and Research, on his or her 
own initiative or at the request of representatives of the Drug 
Enforcement Administration, Department of Justice, National Institute of 
Drug Abuse, the State authority, or any other interested person.
    (2) Before presenting such a proposal to the Commissioner, the 
Director of the Center for Drug Evaluation and Research, or his or her 
representative, will notify the applicant in writing of the proposed 
action and the reasons therefor and will offer the applicant an 
opportunity to explain the matters in question in an informal conference 
and/or in writing within 10 days after receipt of such notification. The 
applicant shall have the right to hear and to question the information 
on which the proposal to deny or revoke approval is based, and may 
present any oral or written information and views.
    (3) If the explanation offered by the applicant is not accepted by 
the Center for Drug Evaluation and Research as sufficient to justify 
approval of the application, and denial or revocation of approval is 
therefore proposed, the Commissioner will evaluate information obtained 
in the informal conference and/or in writing before the Director of the 
Center for Drug Evaluation and Research. If the Commissioner finds that 
the applicant has failed to submit adequate assurance justifying 
approval of the application, the Commissioner shall issue a notice of 
opportunity for hearing with respect to the matter pursuant to 
Sec. 314.200 of this chapter and the matter shall thereafter be handled 
in accordance with established procedures for denial or revocation of 
approval of a new drug application. If the Secretary determines that 
there is an imminent hazard to health, revocation of approval will 
become effective immediately and any administrative procedure will be 
expedited. Upon revocation of approval of an application, the 
Commissioner will notify the applicant, the State authority, the Drug 
Enforcement Administration, Department of Justice, and all other 
appropriate persons that the applicant may no longer receive shipments 
of narcotic drugs, and will require the recall of all of the drugs from 
the applicant. Revocation of approval may also result in criminal 
prosecution.
    (4) Denial or revocation of approval may be reversed when the 
Commissioner determines that the applicant

[[Page 177]]

has justified approval of the application.
    (5) A treatment program or medication unit or any part thereof, 
including any facility or any individual, may appeal to the Food and 
Drug Administration a complete or partial denial or revocation of 
approval by the State authority unless the denial or revocation is based 
upon a State law or regulation. The appeal shall first be made to the 
Director of the Center for Drug Evaluation and Research, who shall hold 
an informal conference on the matter in accordance with paragraph (h)(2) 
of this section. The State authority may participate in the conference. 
The appellant or the State authority may appeal the Director's decision 
to the Commissioner, who shall decide the matter in accordance with 
paragraph (h)(3) of this section. If the Commissioner denies or revokes 
approval, such action shall be handled in accordance with paragraph 
(h)(3) of this section. The Commissioner may not grant or retain Food 
and Drug Administration approval if the Commissioner finds that the 
appellant is not in compliance with all applicable State laws and 
regulations and with this section.
    (i) Sanctions--(1) Program sponsor or individual responsible for a 
particular program. If the program sponsor or the person responsible for 
a particular program fails to abide by all the requirements set forth in 
this regulation, or fails to adequately monitor the activities of those 
employed in the program, he or she may have the approval of his or her 
application revoked, his or her narcotic drug supply seized, an 
injunction granted precluding operation of his or her program, and 
criminal prosecution instituted against him or her.
    (2) Persons responsible for administering or dispensing narcotic 
drugs. If a person responsible for administering or dispensing narcotic 
drugs for narcotic addict treatment fails to abide by all the 
requirements set forth in this regulation, criminal prosecution may be 
instituted against him or her, his or her drug supply may be seized, the 
approval of the program may be revoked, and an injunction may be granted 
precluding operation of the program.
    (j) Requirements for distribution by manufacturers of narcotic drugs 
for narcotic addict treatment--(1) Distribution requirements. Shipments 
of narcotic drugs for narcotic addict treatment are restricted to direct 
shipments by manufacturers of the drugs to approved treatment programs 
using the narcotic drugs and to approved hospital pharmacies. If 
requested by a manufacturer or State authority, wholesale pharmacy 
outlets in some regions or States may be authorized to stock narcotic 
drugs for narcotic addict treatment for that area and then transship the 
drug to approved narcotic treatment programs and approved hospital 
pharmacies. Alternative methods of distribution will be permitted if 
they are approved by the Food and Drug Administration and the State 
authority. Prior to any approval of an alternative method of 
distribution there will be consultation with the Drug Enforcement 
Administration, Department of Justice, to assure compliance with its 
regulations regarding controlled substance distribution.
    (2) Information regarding approved programs and hospitals. The Food 
and Drug Administration will provide manufacturers and the public with 
names and locations of programs and hospitals that have been approved to 
receive shipments of narcotic drugs for narcotic addiction treatment. 
All information contained in the forms required by paragraph (k) of this 
section is available for public disclosure, except the names or other 
identifying information with respect to patients.
    (3) Acceptance of delivery. Delivery shall only be made to a 
licensed practitioner or a licensed pharmacist employed at the facility. 
At the time of delivery the licensed practitioner or licensed pharmacist 
shall sign for the drugs and place his or her specific title and 
identification number on any invoice. Copies of these signed invoices 
shall be kept by the manufacturer.
    (k) Use of narcotics other than methadone in a treatment program. 
Narcotic drug products other than methadone that have been approved for 
treatment of narcotic addiction are listed in paragraph (b)(2)(v) of 
this section. Detailed information on the conditions for use of narcotic 
drug products other than methadone, with the exception of take-home and 
dosage form requirements,

[[Page 178]]

can be found in the respective approved product labeling. Treatment 
programs shall review the most recent approved product labeling for up-
to-date information on important treatment parameters for each drug. 
Deviation from doses, frequencies, and conditions of usage described in 
the approved labeling shall be justified in the patient's record. 
Treatment programs that dispense narcotics other than methadone shall 
conform with the requirements set forth under paragraphs (a), (b), (c), 
(d)(1) through (d)(5), (d)(8) through (d)(14), and (e) through (l) of 
this section. Specifics regarding take-home and dosage form requirements 
along with any additional requirements are set forth in this paragraph.
    (1) LAAM--(i) Dosage and responsibility for administration. After a 
patient's tolerance to LAAM is established, LAAM shall be administered 
no more frequently than every other day. Dosage of LAAM shall be 
individualized at doses, frequencies, and under conditions of usage 
described in approved labeling and as follows:
    (A) New patients. The persons responsible for the program shall 
ensure that the initial dose of LAAM to a patient whose tolerance for 
the drug is unknown does not exceed 40 milligrams.
    (B) Stabilized methadone maintenance patient. The persons 
responsible for the program shall ensure that the initial dose of LAAM 
for a previously stabilized methadone maintenance patient is less than 
or equal to 1.3 times the patient's daily methadone dose, not to exceed 
120 milligrams.
    (C) A licensed physician shall assume responsibility for the amount 
of the narcotic drug administered or dispensed and shall record, date, 
and sign or countersign in each patient's record each change in dosage 
schedule.
    (D) The administering licensed physician shall ensure that a single 
dose of LAAM greater than 140 milligrams is justified in the patient's 
record.
    (ii) Dosage form. LAAM may be administered in oral form when used in 
a maintenance treatment program. Hospitalized patients under care for a 
medical or surgical condition are permitted to receive LAAM in oral form 
when the attending physician judges it advisable. Although syrup 
concentrate or other formulations may be distributed to the program, all 
oral medication is required to be administered in a liquid formulation. 
Clinics that administer both LAAM and methadone shall take appropriate 
measures, including contrasting color and taste, to ensure that dosage 
forms of LAAM and methadone are easily distinguished.
    (iii) Take-home medication. Take-home doses of LAAM are not 
permitted. A patient who is eligible for one or more take-home doses of 
methadone under paragraph (d)(6) of this section and who is unable to 
conform to the applicable mandatory LAAM dosing schedule because of 
exceptional circumstances such as illness, personal or family crises, 
travel, or other hardship, or official State holidays, may be 
temporarily transferred to methadone. Take-home doses of methadone for a 
patient eligible for a planned temporary discontinuation of treatment 
with LAAM shall be individualized at doses, frequencies, and under 
conditions of usage described in the approved labeling and the 
applicable provisions for take-home methadone medication under paragraph 
(d)(6) of this section. The maximum number of take-home doses of 
methadone shall be determined in accordance with the provisions of 21 
CFR 291.505 (d)(6)(v) and (d)(6)(vi).
    (2) [Reserved]
    (l) Program forms. The program sponsor must ensure that the 
following forms are completed by the proper program staff and submitted 
to the appropriate State authority and the Division of Scientific 
Investigations, Regulatory Management Branch (HFD-342), Food and Drug 
Administration, 7520 Standish Pl., Rockville, MD 20855. The sponsor will 
indicate on the appropriate form which treatment drug is being utilized. 
Forms are available upon request from the Regulatory Management Branch 
(HFD-342) at the same address.

                                  Forms

FDA-2632 Application for Approval of Use of Narcotic Drugs in a 
Treatment Program.
FDA-2633 Medical Responsibility Statement for Use of Narcotic Drugs in a 
Treatment Program.
FDA-2635 Consent to Treatment with an Approved Narcotic Drug.

[[Page 179]]

FDA-2636 Hospital Request for Methadone Detoxification Treatment.

(Approved by the Office of Management and Budget under number 0910-0140)

[54 FR 8960, Mar. 2, 1989; 54 FR 12531, Mar. 27, 1989; 58 FR 498, Jan. 
6, 1993; 58 FR 38709, July 20, 1993]